{"id":47427,"date":"2014-06-17T16:16:18","date_gmt":"2014-06-17T20:16:18","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=47427"},"modified":"2014-06-17T16:57:39","modified_gmt":"2014-06-17T20:57:39","slug":"a-missing-link","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/06\/17\/a-missing-link\/","title":{"rendered":"a missing link&#8230;"},"content":{"rendered":"\n<p align=\"justify\">In the last post [<a href=\"http:\/\/1boringoldman.com\/index.php\/2014\/06\/17\/doing-the-right-thing\/\">doing the right thing&hellip;<\/a>], I was praising Canadian Bill C-17 to amend their Food and Drug Act to give the government needed powers to deal with Clinical Trial reporting and drug approval, but I was worried that I couldn&#8217;t find the details [that place where the devil lives]. I was helpfully pointed to some articles in the Toronto Star [Mar 10, 2014 <a target=\"_blank\" href=\"http:\/\/www.thestar.com\/news\/canada\/2014\/03\/10\/proposed_drug_recall_bill_has_too_many_loopholes_health_law_experts_say.html#\">Canadian Medical Association Journal says proposed drug recall bill has too many loopholes<\/a>, May 30, 2014 <a target=\"_blank\" href=\"http:\/\/www.thestar.com\/news\/gta\/2014\/05\/30\/federal_drug_reform_law_approved_for_further_review.html\">Federal drug reform law approved for further review<\/a><span class=\"published-date\">]. They, in turn, lead to an article in the<\/span> <em>Canadian Medical Association Journal<\/em> published online in March and in print in May called <a target=\"_blank\" href=\"http:\/\/www.cmaj.ca\/content\/186\/8\/E287.extract#\">Regulating prescription drugs for patient safety: Does Bill C-17 go far enough?<\/a> [It is neither abstracted nor available on-line past page 1, so we&#8217;re going to have to go with my pulling out key quotes].<\/p>\n<hr size=\"1\" \/>\n<div align=\"justify\" class=\"small\">They began with the problems of the past [readable on page 1]. Then they have a section about what they think is right with the bill:<\/div>\n<ul><span class=\"small\">           <\/p>\n<li>\n<div align=\"justify\"><u><strong><font color=\"#200020\">Power to recall drugs<\/font><\/strong><\/u>: &quot;Bill C-17 empowers the Health Minister to issue a recall, without first entertaining representations from the manufacturer, provided he or she &#8216;believes that a therapeutic product presents a serious or imminent risk of injury to health.&#8217;&quot;<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><font color=\"#200020\">Power to overcome information asymmetries<\/font><\/strong><\/u>:  Bill C-17 enables Ihe Health Minister to compel manufacturers to provide information about drugs. eg information &quot;about a serious adverse drug reaction that involves a therapeutic product or a medical device incident.&quot; &quot;These information-sharing requirements are a major improvement on the status quo.&quot; <\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><font color=\"#200020\">Power to enforce conditions on market authorizations and compel changes to product labels<\/font><\/strong><\/u>: &quot;In 2007, Ihe US Food and Drug Administration (FDA) was granted powers to enforce conditions and to compel changes to a product&#8217;s label in light of safety concerns that emerge after market approval. It is imperative that Health Canada be vested with these powers.&quot;  <\/div>\n<\/li>\n<li>\n<div><u><strong><font color=\"#200020\">Serious enforcement measures<\/font><\/strong><\/u>: &quot;Finally, Bill C-17 creates much stronger penal- ties for failure to comply with some of the provi- sions of the Food and Drugs Act and accompa- nying regulations.These include lines of up to $5 million per day during which the offence is committed, and\/or imprisonment for the most egregious oflences. &quot; <\/div>\n<\/li>\n<p>           <\/span> <\/ul>\n<div align=\"justify\" class=\"small\">Then they moved on to elements that should be added to the proposed legislation:<\/div>\n<ul><span class=\"small\">           <\/p>\n<li>\n<div align=\"justify\"><u><strong><font color=\"#200020\">Enhance the power of recall and alter the ability to suspend<\/font><\/strong><\/u>:<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><font color=\"#200020\">Exempt the Health Minister from liability for drug suspensions and recalls<\/font><\/strong><\/u>: <\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><font color=\"#200020\">Ensure transparency in clinical trials<\/font><\/strong><\/u>: &quot;&#8230; requiring registration by law, and creating a robust mechanism to enforce that requirement, is an important step toward improving the transparency of the evidence base behind drugs and other therapies, and avoiding potential harm to patients.&quot; In addition, making sure that clinical trial data, whether collected before market approval or in postmarket studies, are available for scrutiny by independent researchers is critical to ensuring that treatment and use decisions are evidence-based.&quot;<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><font color=\"#200020\">Enhance transparency in Health Canada&#8217;s decision-making<\/font><\/strong><\/u>:  &quot;Bill C-17 should empower Health Canada to publish both positive and negative regulatory decisions. At minimum. Health Canada should publish the rationales lor decisions concerning all drugs approved for sale, drugs refused for reasons of safety or efficacy, and drugs that are suspended or recalled.&quot; <\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><font color=\"#200020\">Outline clear limits to the scope of proprietary information<\/font><\/strong><\/u>: &quot;Meaningful transparency is hard to achieve in practice, in part because manufacturers often claim that the government is obliged to protect information about the safety and efficacy of a drug as &quot;proprietary,&quot; either as a &quot;trade secret&quot; or as &quot;confidential business information.&quot;&quot; These assertions overstate what the law actually requires and prevent important information about safety and effectiveness from being released.&quot; International treaties simply require Canada to protect trade secrets and confidential business information without specifying the scope of those types of information. No Canadian court decision indicates that information about the safety or efficacy of a drug is proprietary, and current case law casts doubt on any such assertion. In principle. Health Canada can at present disclose greater amounts of safety and efficacy information. <font color=\"#200020\">However, to clarify and to overcome manufacturers&#8217; efforts to resist disclosure, Bill C-17 should explicitly state that the results of clinical trials, including de-identilied patient-level data, poslmarket studies, and adverse drug reactions reported by drug manufacturers and health care institutions, are not proprietary and therefore should be publicly disclosed.<\/font>&quot;<\/div>\n<\/li>\n<li>\n<div align=\"justify\"><u><strong><font color=\"#200020\">Do not allow trade to trump patient safety<\/font><\/strong><\/u>: &quot;Bill C-17 gives the Governor in Council scope to impose stringent rules favouring data protection to the detriment of other powers in the Food and Drugs Act This proposal is fundamentally problematic and must not be enacted.&quot; <\/div>\n<\/li>\n<p>           <\/span><\/ul>\n<div align=\"justify\" class=\"small\"><u><strong><font color=\"#200020\">Conclusion<\/font><\/strong><\/u>: &quot;Bill C-17 is an important step toward the safe regulation of drugs because it enhances the ability of Health Canada to act in the face of threats to public health. It also introduces meaningful enforcement mechanisms, including substantial penalties, for noncompliance. However, it requires amend- ment to incorporate several additional key compo- nents of prescription drug safety. Bill C-17 has the potential to make an important and positive difference to public safety in Canada We urge that Bill C-17 be revised and enhanced before it becomes law so that this potential can he realized.&quot;<\/div>\n<hr size=\"1\" \/>\n<div align=\"justify\">This is the most comprehensive proposal that I&#8217;ve seen to date &#8211; one that directly addresses the Trade Agreements and PHARMA&#8217;s claims about proprietary ownership of Clinical Trial Data. And what&#8217;s totally amazing, it&#8217;s in a medical journal! a big medical journal! instead of just lolling on some blog at the rim of the galaxy. And from the blurb I&#8217;ve quoted already [<a href=\"http:\/\/www.digitaljournal.com\/pr\/1991187\" target=\"_blank\">House of Commons adopts government strengthened patient safety legislation<\/a>], these suggestions look to have become the amendments that have passed the House of Commons and are headed to the Canadian Senate:  <\/div>\n<ul><span class=\"small\"><\/p>\n<div align=\"justify\"><font color=\"#200020\">The amendments to Bill C-17 were introduced by Member of Parliament,  Terrence Young and adopted by the House of Commons Standing Committee  on Health on June 12. The Bill has now passed Third Reading in the  House of Commons and moves to the Senate for consideration. The  amendments include the requirement that both positive and negative  decisions about drug authorizations be disclosed on a public website;  and that clinical trial information be disclosed on a public registry.  The amendments also better define the scope of confidential business  information [CBI] and allow the Minister to disclose CBI about a  product if the Minister believes the product may pose a serious risk to  Canadians. <\/font><\/div>\n<p><\/span><\/ul>\n<div align=\"justify\">Like I said, Canada seems <em>&quot;poised to be quietly just doing the right thing.<\/em>&quot; May the force be with them&#8230;<\/div>\n","protected":false},"excerpt":{"rendered":"<p>In the last post [doing the right thing&hellip;], I was praising Canadian Bill C-17 to amend their Food and Drug Act to give the government needed powers to deal with Clinical Trial reporting and drug approval, but I was worried that I couldn&#8217;t find the details [that place where the devil lives]. I was helpfully [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-47427","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47427","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=47427"}],"version-history":[{"count":25,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47427\/revisions"}],"predecessor-version":[{"id":47452,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47427\/revisions\/47452"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=47427"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=47427"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=47427"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}